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Evaluation of Droplet Digital PCR Rapid Detection Method and Precise Diagnosis and Treatment for Suspected Sepsis

Primary Purpose

Sepsis, Septic Shock

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
droplet digital PCR method
blood culture
Sponsored by
Huashan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sepsis focused on measuring Digital Droplet PCR, Etiology Diagnose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1.18 years or older

2.Meet 2 of 4 sepsis criteria

  1. Temperature > 38C or < 36C
  2. Heart rate > 90 bpm
  3. Respiratory rate >20 or PaCO2 <32mmHg

  4. WBC >12000/µL or < 4000/µL or > 10% bands

    3.Hospitalized patients who have a diagnostic blood culture ordered as standard of care for suspected sepsis

    4.Informed Consent by patient or legal representative.

    Exclusion Criteria:

    1. Refusal to participate in the study or Failure to comply with treatment or follow-up time
    2. Known breastfeeding or pregnancy
    3. The researcher believes that there are any conditions (social or medical) that allow subjects to participate is unsafe. For example, severe anemia or high risk of bleeding,etc., which are not suitable for taking peripheral blood for testing
    4. Participating in other clinical studies

Sites / Locations

  • The First Affiliated Hospital of Anhui Medical UniversityRecruiting
  • Xiangya Hospital Central South University
  • Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese MedicineRecruiting
  • Wuxi No.5 People's HospitalRecruiting
  • Xinhua Hospital Affliated to Shanghai Jiao Tong University School of Medicine
  • Shanghai Sixth People's Hospital
  • Minhang Branch of Ruijin Hospital
  • Zhejiang Rui'an People's HospitalRecruiting
  • The First Affiliated Hospital of Wenzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

droplet digital PCR method

blood culture only

Arm Description

Pathogen detection by droplet digital PCR method as an adjunct to traditional microbiological assessments including blood culture

Pathogen detection by microbiological assessments including blood culture

Outcomes

Primary Outcome Measures

Sensitivity
The primary endpoint of estimated sensitivity will be determined by comparing positive blood culture results with the concomitantly collected ddPCR results from the prospective clinical specimens.
Specificity
The primary endpoint of estimated specificity will be determined by comparing negative blood culture results with the concomitantly collected ddPCR results from the prospective clinical specimens.

Secondary Outcome Measures

Time to the change to the targeted antimicrobial therapy
Number of patients with targeted antimicrobial therapy
Time to identification of a potential pathogen
Duration of antimicrobials
Change in condition severity
The sequential organ failure assessment score (SOFA score), previously known as the sepsis-related organ failure assessment score, higher scores mean worse outcome.
Days in intensive care unit (ICU)
Ventilation duration in ICU (hours)
Days in hospital (from study inclusion)
All-cause death
Treatment costs
Quality of life of survivors after being discharged
EQ-5D, a standardised measure of health-related quality of life developed by the EuroQol Group.The EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The number of levels in these dimensions is 5 in the EQ-5D-5L. Higher levels mean worse health states.

Full Information

First Posted
November 25, 2021
Last Updated
January 12, 2022
Sponsor
Huashan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05190861
Brief Title
Evaluation of Droplet Digital PCR Rapid Detection Method and Precise Diagnosis and Treatment for Suspected Sepsis
Official Title
Evaluation of Droplet Digital PCR Rapid Detection Method and Precise Diagnosis and Treatment for Suspected Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Sepsis is a significant public health concern worldwide, with high morbidity and mortality. With regard to a targeted antimicrobial treatment strategy, the earliest possible pathogen detection is of crucial importance. Until now, culture-based detection methods represent the diagnostic gold standard, although they are characterized by numerous limitations. Culture-independent molecular diagnostic procedures may represent a promising alternative. In particular, droplet digital PCR (ddPCR) is a novel one-step PCR assay that achieves higher accuracy and sensitivity in detecting causing pathogens in patients with bloodstream infections.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Septic Shock
Keywords
Digital Droplet PCR, Etiology Diagnose

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
droplet digital PCR method
Arm Type
Experimental
Arm Description
Pathogen detection by droplet digital PCR method as an adjunct to traditional microbiological assessments including blood culture
Arm Title
blood culture only
Arm Type
Active Comparator
Arm Description
Pathogen detection by microbiological assessments including blood culture
Intervention Type
Diagnostic Test
Intervention Name(s)
droplet digital PCR method
Intervention Description
The droplet digital PCR method can detect nucleic acids from the most common pathogens (approximately 90%) responsible for BSIs according to Chinet2020 and takes about 4 hours to perform, reporting within the first 24h of suspected sepsis/septic shock.
Intervention Type
Diagnostic Test
Intervention Name(s)
blood culture
Intervention Description
Blood culture is a conventional microbiological method of pathogen detection. Results from blood cultures are usually not available until 24 to 72 hours after sampling.
Primary Outcome Measure Information:
Title
Sensitivity
Description
The primary endpoint of estimated sensitivity will be determined by comparing positive blood culture results with the concomitantly collected ddPCR results from the prospective clinical specimens.
Time Frame
Up to 96 hours post blood collection
Title
Specificity
Description
The primary endpoint of estimated specificity will be determined by comparing negative blood culture results with the concomitantly collected ddPCR results from the prospective clinical specimens.
Time Frame
Up to 96 hours post blood collection
Secondary Outcome Measure Information:
Title
Time to the change to the targeted antimicrobial therapy
Time Frame
At time point of change to the targeted antimicrobial therapy, up to 96 hours post blood collection
Title
Number of patients with targeted antimicrobial therapy
Time Frame
Up to the end of study participation, an average of 1 year
Title
Time to identification of a potential pathogen
Time Frame
At time point of identification of a potential pathogen, up to 96 hours post blood collection
Title
Duration of antimicrobials
Time Frame
Up to the end of study participation, an average of 1 year
Title
Change in condition severity
Description
The sequential organ failure assessment score (SOFA score), previously known as the sepsis-related organ failure assessment score, higher scores mean worse outcome.
Time Frame
Up to the end of study participation, an average of 1 year
Title
Days in intensive care unit (ICU)
Time Frame
Up to the end of study participation, an average of 1 year
Title
Ventilation duration in ICU (hours)
Time Frame
Up to the end of study participation, an average of 1 year
Title
Days in hospital (from study inclusion)
Time Frame
Up to the end of study participation, an average of 1 year
Title
All-cause death
Time Frame
Up to the end of study participation, an average of 1 year
Title
Treatment costs
Time Frame
Up to the end of study participation, an average of 1 year
Title
Quality of life of survivors after being discharged
Description
EQ-5D, a standardised measure of health-related quality of life developed by the EuroQol Group.The EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The number of levels in these dimensions is 5 in the EQ-5D-5L. Higher levels mean worse health states.
Time Frame
Up to the end of study participation, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.18 years or older 2.Meet 2 of 4 sepsis criteria Temperature > 38C or < 36C Heart rate > 90 bpm Respiratory rate >20 or PaCO2 <32mmHg WBC >12000/µL or < 4000/µL or > 10% bands 3.Hospitalized patients who have a diagnostic blood culture ordered as standard of care for suspected sepsis 4.Informed Consent by patient or legal representative. Exclusion Criteria: Refusal to participate in the study or Failure to comply with treatment or follow-up time Known breastfeeding or pregnancy The researcher believes that there are any conditions (social or medical) that allow subjects to participate is unsafe. For example, severe anemia or high risk of bleeding,etc., which are not suitable for taking peripheral blood for testing Participating in other clinical studies
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Ye
Phone
13856980361
Email
yeying2@139.com
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Huang
Phone
13874854142
Email
drhyan@163.com
Facility Name
Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanliang Zhang
Phone
13815440366
Email
swinburn@163.com
Facility Name
Wuxi No.5 People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Liu
Phone
15949255828
Email
15949255828@126.com
Facility Name
Xinhua Hospital Affliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisu Huang
Phone
18221099971
Email
huanglisu@126.com
Facility Name
Shanghai Sixth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohua Chen
Phone
18930172758
Email
chenxiaohua2000@163.com
Facility Name
Minhang Branch of Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201100
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Li
Phone
18918169826
Email
18918169826@163.com
Facility Name
Zhejiang Rui'an People's Hospital
City
Rui'an
State/Province
Zhejiang
ZIP/Postal Code
325200
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Hong
Phone
13958805550
Email
381718299@qq.com
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingye Pan
Phone
13566289666
Email
panjingye@wzhospital.cn

12. IPD Sharing Statement

Citations:
PubMed Identifier
35854212
Citation
Zhao Y, Lin K, Zhang H, Yuan G, Zhang Y, Pan J, Hong L, Huang Y, Ye Y, Huang L, Chen X, Liu J, Li X, He X, Yue Q, Zhang H, Zhou A, Zhuang Y, Chen J, Wu C, Zhou W, Cai F, Zhang S, Li L, Li S, Bian T, Li J, Yin J, Ruan Z, Xu S, Zhang Y, Chen J, Zhang Y, Han J, Su T, Tu F, Jiang L, Lei C, Du Q, Ai J, Zhang W. Evaluation of droplet digital PCR rapid detection method and precise diagnosis and treatment for suspected sepsis (PROGRESS): a study protocol for a multi-center pragmatic randomized controlled trial. BMC Infect Dis. 2022 Jul 19;22(1):630. doi: 10.1186/s12879-022-07557-2.
Results Reference
derived

Learn more about this trial

Evaluation of Droplet Digital PCR Rapid Detection Method and Precise Diagnosis and Treatment for Suspected Sepsis

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